Motor Rehabilitation and Physical, Mental and Cognitive Health in Patients With Stroke

NCT ID: NCT06840366

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2025-05-17

Brief Summary

This study analyzes the effectiveness of a motor rehabilitation program in the functional recovery of stroke patients and its impact physiotherapy, occupational therapy, and neuropsychology are used to measure improvements in balance, mobility, independence in daily activities, and cognitive functions. The intervention involves the use of the Lokomat, a technologically advanced robot-assisted gait training device. Patients are supported in a harness on a treadmill while the robotic system guides their legs through a natural gait cycle. The results will help clarify the relationship between motor recovery and overall well-being, providing evidence to optimize therapeutic strategies for stroke patients.

Conditions

ACV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lokomat Group

The intervention group will be composed of patients who have suffered a stroke and have alterations in mobility, balance and gait. These patients will be selected according to inclusion criteria such as clinical stability and ability to participate in a rehabilitation program. The group will receive structured physiotherapy sessions with a progressive approach to improve postural control, muscle strength, coordination and functional independence.

Group Type: EXPERIMENTAL

Lokomat intervention

Intervention Type: OTHER

The intervention will consist of an 8-week motor rehabilitation program, with 3 weekly sessions of 60 minutes each. In the first weeks, joint mobilization and postural control in a sitting position will be worked on, followed by muscle strengthening and balance re-education in a standing position. Subsequently, coordination exercises and assisted walking on different surfaces will be incorporated. In the final phase, independent walking and the integration of functional movements in daily life activities will be encouraged. The program will be adapted to the individual needs of each patient to optimize recovery and improve quality of life.

Interventions

Lokomat intervention

The intervention will consist of an 8-week motor rehabilitation program, with 3 weekly sessions of 60 minutes each. In the first weeks, joint mobilization and postural control in a sitting position will be worked on, followed by muscle strengthening and balance re-education in a standing position. Subsequently, coordination exercises and assisted walking on different surfaces will be incorporated. In the final phase, independent walking and the integration of functional movements in daily life activities will be encouraged. The program will be adapted to the individual needs of each patient to optimize recovery and improve quality of life.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of ischemic or hemorrhagic stroke.
• Age equal to or greater than 18 years.
• Patients in the subacute or chronic phase of stroke (≥ 3 months since the event).
• Ability to participate in a motor rehabilitation program.
• Absence of advanced neurodegenerative diseases that may interfere with the evaluation of results.
• Ability to understand and follow basic instructions of the rehabilitation program.
• Informed consent signed by the patient or his/her legal representative.

Exclusion Criteria

• People under 60 years of age.
• Presence of serious comorbidities that prevent physical activity or rehabilitation (e.g. severe heart failure, advanced chronic obstructive pulmonary disease).
• Patients with severe cognitive impairments that make it difficult to follow the program (e.g. advanced dementia).
• Use of drugs that significantly affect motor and cognitive function, interfering with the evaluation of rehabilitation.
• Presence of active infections or unstable medical conditions requiring hospitalization.
• History of another neurological disorder that may affect functional recovery (e.g. Parkinson's disease, multiple sclerosis).
• Participation in another rehabilitation program at the same time, which may interfere with the results of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Agustín Aibar Almazán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Agustín Aibar Almazán

Jaén, , Spain

Countries

Spain

Other Identifiers

*University of Jaén.

Identifier Type: -

Identifier Source: org_study_id